Purpose

Contact lens discomfort (CLD) is a major concern that can lead to the decreased or abandoned use of contact lenses. Contact lens users with dry eye disease are more likely to present with CLD. This study was conducted to evaluate the efficacy of a bioprotective preservative free, hypotonic, 0.15% hyaluronic acid (HA)-3% Trehalose artificial tear in managing dry eye symptoms in contact lens wearers.

Methods

A prospective, single-arm, observational pilot study to evaluate the effectiveness of treatment with HA-Trehalose artificial tears in contact lens wearers (N = 33) aged 18–45 years with symptoms of ocular discomfort. Participants used a preservative-free, hypotonic HA-Trehalose artificial tear (1 drop/4 times per day) for 84 days. Participants were assessed using Visual Analogue Scale (VAS) for dry eye symptoms (pain, photophobia, dry eye sensation, blurry vision, foreign body sensation, itching, tingling/burning, and sticky eye feeling), Ocular Surface Disease Index (OSDI), Contact Lens Dry Eye questionnaire (CLDEQ-8), Berkley Dry Eye Flow-Chart (DEFC) on Day 0 and Day 84 and tear break-up time (TBUT), ocular surface staining with fluorescein and lissamine green, tear meniscus evaluation, and visual acuity on Day 0, 35, and 84.

Results

All VAS symptoms (except tingling/burning and sticky eye feeling), OSDI, CLEDQ-8, and DEFC showed statistically significant (p < 0.05) improvement from baseline (Day 0) to Day 84. Similarly, corneal (fluorescein) and conjunctival (lissamine green) quality improved during the study (p < 0.05 at Day 84 versus baseline). Tear break-up time (TBUT), conjunctival (lissamine green) staining, and tear meniscus decreased but the changes were not statistically significant. Visual acuity did not change during the study. There were no ocular or systemic adverse events.

Conclusions

This study showed that the instillation of a preservative-free, hypotonic, HA-Trehalose artificial tear in contact lenses wearers with dry eye syndrome significantly improved symptoms and reduced associated signs such as corneal and conjunctival staining.

中文翻译：

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改善隐形眼镜佩戴者的眼表舒适度

目的

隐形眼镜不适 (CLD) 是一个主要问题，可导致隐形眼镜的使用减少或放弃。患有干眼症的隐形眼镜使用者更有可能出现 CLD。本研究旨在评估不含生物保护防腐剂、低渗、0.15% 透明质酸 (HA)-3% 海藻糖人工泪液在治疗隐形眼镜佩戴者干眼症状方面的功效。

方法

一项前瞻性、单臂、观察性试验研究，旨在评估 HA-海藻糖人工泪液对 18-45 岁有眼部不适症状的隐形眼镜佩戴者 (N = 33) 治疗的有效性。参与者使用不含防腐剂的低渗 HA-海藻糖人工泪液（每天 1 滴/4 次）持续 84 天。使用视觉模拟量表 (VAS) 评估参与者的干眼症状（疼痛、畏光、干眼感、视力模糊、异物感、瘙痒、刺痛/灼热和粘眼感）、眼表疾病指数 (OSDI)、隐形眼镜干眼问卷 (CLDEQ-8)、第 0 天和第 84 天的伯克利干眼流程图 (DEFC) 和泪液破裂时间 (TBUT)、用荧光素和丽丝胺绿染色的眼表、泪液半月板评估和第 0、35 和 84 天的视力。

结果

从基线（第 0 天）到第 84 天，所有 VAS 症状（刺痛/灼热和粘眼感除外）、OSDI、CLEDQ-8 和 DEFC 均显示出统计学上显着的改善（p < 0.05）。类似地，角膜（荧光素）和结膜（ lissamine green）质量在研究期间得到改善（第 84 天与基线相比 p < 0.05）。泪液破裂时间（TBUT）、结膜（丽丝胺绿）染色和泪液半月板减少，但变化无统计学意义。研究期间视力没有变化。没有眼部或全身性不良事件。

结论

这项研究表明，在患有干眼症的隐形眼镜佩戴者中滴注无防腐剂、低渗 HA-海藻糖人工泪液可显着改善症状并减少相关体征，例如角膜和结膜染色。